Efficacy of Changing to DUOTRAV® From Prior Therapy

NCT01327599 | Completed Phase 4 Results

• 2 other identifiers: RDG-10-2722011-000161-13
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).

Conditions

Open-Angle Glaucoma; Ocular Hypertension; Pigment Dispersion Glaucoma

Keywords

Open-angle glaucoma; Ocular hypertension; Pigment dispersion glaucoma; Intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline

  IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.

  Week 12

Secondary Outcomes (4)

• Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline

  Week 12

• Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline

  Week 12

• Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline

  Week 4, Week 12

• Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline

  Week 4

Study Arms (1)

DUOTRAV®

EXPERIMENTAL

Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks

Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solution

Interventions

Travoprost 0.004%+Timolol 0.5% ophthalmic solution DRUG

Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)

Also known as: DUOTRAV®

DUOTRAV®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
• Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
• IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
• IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
• Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
• Able to follow instructions and willing and able to attend all study visits.
• Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
• Sign informed consent.

You may not qualify if:

• Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
• Corneal dystrophies in either eye.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• History of severe allergic rhinitis.
• A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
• Participation in any other investigational study within 30 days prior to the Screening Visit.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost; Timolol; Ophthalmic Solutions; Duotrav

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Doug Hubatsch, Therapeutic Unit Head, Global Medical Affairs
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Severine Durier, Pharm.D

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 1, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 10, 2014
• Results First Posted: January 10, 2014

Record last verified: 2014-01